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A study comparing two ways of giving the medicine dexamethasone (by mouth inhalation through a nebulizer vs injection into the vein) to see which better prevents sore throat after spine surgery done in the face-down position.

Effect of Preemptive Dexamethasone via nebulization versus intravenous route on Postoperative sore throat after spine surgery in prone position: A Randomised, Double-blinded study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/095560
Enrollment
160
Registered
2025-10-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group N - Nebulization with dexamethasone: Upon arrival in the preoperative room, the patients will receive nebulization with a 5 ml solution for 15-20 minutes and intravenous injection

Sponsors

Dr Sunaina Tejpal Karna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists physical status (ASA) I & II Patients undergoing Spine surgery in the prone position under General anaesthesia with endotracheal intubation with an armoured tube Providing written informed consent for study participation

Exclusion criteria

Exclusion criteria: Cervical spine surgery Pregnant or breastfeeding females Patients already on steroid therapy or having taken steroids in any form 12 hours before surgery Patients with ongoing sore throat or pain in the throat or asthma or hoarse voice or history of respiratory tract infection or sore throat in the 2 weeks before surgery Diabetes mellitus Immunocompromised patients Impaired renal cardiac or hepatic function Patient with psychiatric disorders or antipsychotic therapy Allergy to Dexamethasone More than three attempts are required for intubation The patient needs postoperative mechanical ventilation in the intensive care unit

Design outcomes

Primary

MeasureTime frame
Incidence of Postoperative sore throat (POST) between both the groupsTimepoint: At 2, 6, 12, and 24 hours after surgery

Secondary

MeasureTime frame
Grade of POST on a 4-point scale in between both the groupsTimepoint: at 2, 6, 12, and 24 hours after surgery;Incidence of hoarseness of voice, dysphagia, stridorTimepoint: At 2,6, 12, 24 hours after surgery;Incidence of postoperative nausea and vomiting atTimepoint: At 2, 6, 12, 24 hours after surgery;Quality of recovery with QoR-15 scoreTimepoint: At 48 hours and 1 week after surgery

Countries

India

Contacts

Public ContactSunaina Tejpal Karna

AIIMS Bhopal

drtejpal@gmail.com09540946869

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026